Retractor with inflatable blades

ABSTRACT

A surgical retractor is configured to provide surgical access in thoracic surgery, for example through an intercostal incision. The surgical retractor includes at least one inflated or inflatable member to cushion the ribs and surrounding tissue from injury or trauma. In one embodiment, the inflatable member is configured as an inflatable ring with a concave outer surface for engaging and spreading apart two adjacent ribs when the ring is inflated. In another embodiment, the inflatable ring can be combined with a substantially rigid inner ring for supporting and rigidifying the retractor. In yet another embodiment, a plurality of substantially rigid retractor blades is mounted on a spreading track or the like. One or more inflatable members or an inflatable ring are used to cushion the tissue from the rigid retractor blades.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.60/519,512, filed on Nov. 12, 2003. This and all patents and patentapplications referred to herein are hereby incorporated by reference intheir entirety.

FIELD OF THE INVENTION

The invention pertains to apparatus and methods for surgical retraction.In particular, it is a retractor with an inflatable retraction member ora cushion to inhibit trauma to the patient's tissues and organs duringretraction.

BACKGROUND OF THE INVENTION

Surgery on the heart is one of the most commonly performed types ofsurgery that is done in hospitals across the U.S. Cardiac surgery caninvolve the correction of defects in the valves of the heart, defects tothe veins or the arteries of the heart and defects such as aneurysms andthromboses that relate to the circulation of blood from the heart to thebody. Coronary artery bypass graft (CABG) surgery is one of the mostcommon cardiac surgery procedures. In the past, most cardiac surgery wasperformed as open-chest surgery, in which a primary median sternotomywas performed. That procedure involves vertical midline skin incisionfrom just below the super sternal notch to a point one to threecentimeters below the tip of the xiphoid.

This is followed by scoring the sternum with a cautery, then dividingthe sternum down the midline and spreading the sternal edges to exposethe area of the heart in the thoracic cavity. This technique causessignificant physical trauma to the patient and can require one week ofhospital recovery time and up to eight weeks of convalescence. This canbe very expensive in terms of hospital costs and disability, to saynothing of the pain to the patient.

Recently, attempts have been made to change such invasive surgery tominimize the trauma to the patient, to allow the patient to recover morerapidly and to minimize the cost involved in the process. New surgicaltechniques have been developed which are less invasive and traumaticthan the standard open-chest surgery. This is generally referred to asminimally-invasive surgery. One of the key aspects of the minimallyinvasive techniques is the use of a trocar cannula as an entry port forthe surgical instruments. In general, minimally invasive surgery entailsseveral steps: (1) at least one, and preferably at least two,intercostal incisions are made to provide an entry position for atrocar; (2) a trocar is inserted through the incision to provide anaccess channel to the region in which the surgery is to take place,e.g., the thoracic cavity; (3) a videoscope is provided through anotheraccess port to image the internal region (e.g., the heart) to beoperated on; (4) an instrument is inserted through the trocar channel,and (5) the surgeon performs the indicated surgery using the instrumentsinserted through the access channel. Prior to steps (1)-(5), the patientmay be prepared for surgery by placing him or her on a cardiopulmonarybypass (CPB) system and the appropriate anesthesia, then maintaining theCPB and anesthesia throughout the operation. See U.S. Pat. No. 5,452,733to Sterman et al. issued Sep. 26, 1995 for a discussion of thistechnique.

While this procedure has the advantage of being less invasive ortraumatic than performing a media, sternotomy, there are numerousdisadvantages to using trocars to establish the entry ports for theinstruments and viewscope. For example, the trocars are basically“screwed” into position through the intercostal incision. Thistraumatizes the local tissues and nerve cells surrounding the trocar.

Once in place, the trocar provides a narrow cylindrical channel having arelatively small circular cross-section. This minimizes the movement ofthe instrument relative to the longitudinal axis and requiresspecially-designed instruments for the surgeon to perform the desiredoperation (See, e.g., the Sterman patent U.S. Pat. No. 5,452,733). Inaddition, because of the limited movement, the surgeon often has toforce the instrument into an angle that moves the trocar and furtherdamages the surrounding tissue and nerves. The need to force theinstrument causes the surgeon to lose sensitivity and tactile feedback,thus making the surgery more difficult. The surgical retractor of thisinvention is designed to reduce the initial trauma to the patient inproviding access to the internal region, to reduce the trauma to thepatient during surgery, to provide the surgeon with greater sensitivityand tactile feedback during surgery, and to allow the surgeon to useinstruments of a more standard design in performing the non-invasivesurgery.

Other less invasive surgical techniques include access to the region ofthe heart to be corrected by anterior mediastinotomy or a thoracotomy.In a mediastinotomy, a parasternal incision is made that is two to threeinches in length on the left or the right of the patient's sternumaccording to the cardiac structure that needs the attention in thesurgery. Either the third or the fourth costal cartilage is exciseddepending on the size of the heart. This provides a smaller area ofsurgical access to the heart that is generally less traumatic to thepatient. A thoracotomy is generally begun with an incision in the fourthor fifth intercostal space, i.e. the space between ribs 4 and 5 or ribs5 and 6. Once an incision is made, it is completed to lay openunderlying area by spreading the ribs. A retractor is used to enlargethe space between the ribs.

At the present time, when either of these techniques are used, aretractor is used to keep the ribs and soft tissues apart and expose thearea to be operated on to the surgeon who is then able to work in thesurgical field to perform the operation. The types of retractors thatare used may be seen, for example, in volume 1 of Cardiac Surgery byJohn W. Kirkland and Brian G. Barratt-Boyes, Second Edition, Chapter 2,at page 101. Commercial-type retractors for minimally-invasive surgerythat are useful for a mediastinotomy or a thoracotomy are manufacturedby Snowden Pencer (the ENDOCABG rib spreader and retractor), U.S.Surgical (the mini CABG system), and Cardiothoracic Systems (the CTSMIDCAB. System). The ENDOCABG refractor is two opposing retractor armsthat are interconnected by a ratchet arm having a thumbscrew which canadjust the distance between the retractor arms. While this provides auseful retractor, it has certain shortcomings in its ease of use. Themini CABG System is an oval-based platform to which a number ofretractors are then fitted around the extremity of the universal ringbase and adjusted by a gear tooth connection. Each of the retractorshave to be separately adjusted and there are other devices that can beconnected to the universal base which can aid the surgeon in damping theheart movement to better work on the artery or vessel to which thesurgeon is directing his attention. The CTS MIDCAB. System serves asimilar function to the ENDOCABG retractor, but is more complex.

Off-pump coronary artery bypass (OPCAB) surgery is a variation of theCABG procedure that is performed on a patient's beating heart. OPCABsurgery can be performed using minimally invasive techniques or using asternotomy or other thoracotomy for surgical access. A tissue stabilizeris often used for stabilizing an area of tissue on the patient's beatingheart to facilitate an anastomosis between the graft vessel and thecoronary artery. Examples of tissue stabilizers for OPCAB surgery aredescribed in PCT International Patent Application WO 01/58362 Tissuestabilizer and in U.S. Pat. No. 6,755,780 Method and apparatus fortemporarily immobilizing a local area of tissue. Such tissue stabilizersare typically mounted to the surgical retractor or to the surgical tableto provide a stable platform for immobilizing the area of tissue.

A disadvantage of current surgical retractors is that they can causeinjury or trauma to the tissues surrounding the incision. It would bedesirable therefore to provide a surgical retractor that providesconvenient surgical access without cause injury or trauma to thesurrounding tissues.

SUMMARY OF THE INVENTION

In keeping with the foregoing discussion, the present invention providesa surgical retractor especially adapted for providing surgical access inthoracic surgery, for example through an intercostal incision. Thesurgical retractor includes at least one inflated or inflatable memberto cushion the ribs and surrounding tissue from injury or trauma. In oneembodiment, the inflatable member is configured as an inflatable ringwith a concave outer surface for engaging and spreading apart twoadjacent ribs when the ring is inflated. In another embodiment, theinflatable ring can be combined with a substantially rigid inner ringfor supporting and rigidifying the retractor. In yet another embodiment,a plurality of substantially rigid retractor blades is mounted on aspreading track or the like. One or more inflatable members or aninflatable ring are used to cushion the tissue from the rigid retractorblades.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a retractor located within an incision through a patient'sskin and tissue.

FIG. 2 shows a cross section of the retractor shown in FIG. 1.

FIG. 3 is a cross section of a second embodiment of the retractor.

FIG. 4 shows a third embodiment of the retractor.

DETAILED DESCRIPTION

FIG. 1 shows a retractor located within an incision through a patient'sskin and tissue. The retractor is an inflatable ring 102 that assists increating a space or opening 104, for example between two ribs R duringthoracic surgery. The size and shape of the ring 102 may be designed tooptimize the resulting opening 104 for a particular surgical procedure,to provide protection for anatomical structures, or to accommodateanatomical limitations.

FIG. 2 shows a cross section of the retractor 100 shown in FIG. 1. Inthis case, each side of the inflatable ring 102 of the retractor 100presses outward on the two adjacent ribs R. The soft, resilient natureof the ring 102 allows the user to create the necessary opening 104non-traumatically and also provide protection to one or more adjacentnerves, such as the intercostal nerve N, or other sensitive anatomicalstructures. In this case, the outer surface 106 of the retractor isconcave to conform to the shape of the ribs R. The concave outer surface106 may extend symmetrically all the way around the outside of theinflatable ring 102. Alternatively, the inflatable ring 102 of theretractor may be divided into segments or portions specially configuredfor their intended purposes. For example, as indicated in FIG. 1, theinflatable ring 102 of the retractor may configured with a first portion110 having a first concave outer surface 106 for engaging a first rib Rand a second portion 112 having a second concave outer surface 106 forengaging a second rib R. A first inflatable column member 114 and asecond inflatable column member 116 are positioned between the firstportion 110 and the second portion 112 of the inflatable ring 102. Thefirst inflatable column member 114 and the second inflatable columnmember 116 may have a greater cross sectional area than the firstportion 110 and the second portion 112 in order to provide greater forceto separate the first rib and the second rib when inflated.

For different applications, the shape of the retractor 100 may bealtered into different geometries to protect, inhibit contact with orengage selected portions of the anatomy, such as avoiding pressure onthe intercostal nerve. For example, a hole, depression, groove or otheropening 108 may be formed in the inflatable member to avoid contact witha particular section of tissue or to provide access during the surgicalprocedure. Alternately, a bump, ridge or other projection may be presentto engage or create a depression in the tissue, such as to inhibitmovement of the retractor, etc.

FIG. 3 is a cross section of a second embodiment of the retractor 120.In this embodiment, a concave retractor blade or ring 122 is coveredwith a resilient material or inflatable bladder 124 to non-traumaticallycreate and maintain an opening 126 between a patient's ribs R. The blade122 or other solid piece of material may be used as a platform to holdother objects, such as a tissue stabilizer, a positioner, a secondretractor, an ablation element, syringe or other injection device forinjection of drugs or other injectables, etc. A rod or other connectingmeans 130 may be used to fixedly or adjustably position and secure thesurgical or medical tool 128. Adjustment mechanisms may include, but arenot limited to, a swivel, a hinge, a malleable member, a ball andsocket, a ball and collet, snap-on fittings or other known fixed oradjustable connectors.

In a particularly preferred embodiment, the surgical or medical tool 128attached to the retractor 120 is a tissue stabilizer for stabilizing anarea of tissue on the patient's beating heart for performing an off-pumpcoronary artery bypass (OPCAB) surgery.

FIG. 4 shows a third embodiment of the retractor 140. In thisembodiment, two discrete rigid blades 142 are mounted on a spreadingtrack 144. Once the initial incision is made with the scalpel, theblades 142, located closely together on the spreading track 144, areinserted into the incision. The tissue contacting surface of the blades,in this case the outside surfaces, have a resilient surface 146 tonon-traumatically engage the tissue. The resilient surface 146 may be asoft gel coating or a filled or an inflatable bladder containing ordesigned to contain air, gas, gel, silicone, saline or other material.Preferably, the retractor 140 includes a mechanism, for example a rackand pinion with a crank, can be used to forcibly separate the retractorblades 142 to create a space 148 for surgical access through theintercostal incision.

Alternatively, two or more blades 142 may be used to provide structuralsupport for an inflatable ring 102, similar to the embodiment describedin FIG. 1, in place of the resilient surface 146 in FIG. 4, such thatthe blades 142 would support the inflatable ring 102 to hold the ribs Rand the inflatable ring 102 would protect the tissue from instrumentsbeing passed through the opening 148. For example, between 4 and 12 ormore blades could be collapsably and releasably mounted on a ring orrod, similar in function to the spreading track 144 of FIG. 4. Once thering or rod is in the incision, the blades 142 are deployed and the ringor rod could be removed. Then, the inflatable ring 102 located on theouter perimeter of the blades could be inflated to press against thetissue. Alternately, the inflatable ring 102 could be fully or partiallyinflated to provide protection for the tissue prior to deploying theblades. For especially delicate tissue or precise placement of theretractor, deployment could be accomplished in a series of stages wherethe inflatable ring 102 and blades 142 are alternately advanced outward.

Alternatively, a set of inflatable blades could be used alone or incombination with an inflatable bladder. The rigidity of the blades couldbe selected to be more or less than the bladder to provide morestructural support. This could be accomplished by reinforcing the shapewith stiffening elements or by using a greater inflation pressure in theblades.

The blade 142 may include a connector for holding one or more surgicalor medical tools 128, as described above in connection with FIG. 3.

The retractor may be formed with a rigid metal frame that providessupport for the inflatable retraction blades or surfaces. The metalframe may be an integrally formed wire mesh around 30 which theinflatable portion(s) are formed. Alternatively, the frame may be usedonly during insertion of the inflatable member. Once in place, theretractor is inflated, thereby securing it within the percutaneousopening. At this point, the metal frame may be removed. The metal framemay be a mesh or a solid surface. The frame may be embedded into one ofthe walls of the inflatable member, or the inflatable member may beovermolded onto the frame.

Inflation of the bladder, blades or retractor may be accomplished by amanual or automatic pump.

To avoid overinflation, the bladder could be designed with a selectedrupture pressure and/or pattern. In these cases, a medically safematerial, such as saline, could be used.

While the present invention has been described herein with respect tothe exemplary embodiments and the best mode for practicing theinvention, it will be apparent to one of ordinary skill in the art thatmany modifications, improvements and subcombinations of the variousembodiments, adaptations and variations can be made to the inventionwithout departing from the spirit and scope thereof.

1. A surgical retractor comprising: an inflatable ring-shaped member,the inflatable ring-shaped member having a deflated state and aninflated state; when in the inflated state, the inflatable ring-shapedmember defining an inner opening for surgical access through thesurgical retractor; the inflated ring-shaped member having an outersurface with a first concave surface sized and configured to engage afirst rib of a patient adjacent to an intercostal incision and a secondconcave surface, diametrically opposed to the first concave surface,sized and configured to engage a second adjoining rib adjacent to theintercostal incision; wherein the inflatable ring-shaped member isconfigured to provide sufficient force, when inflated, to separate thefirst rib and the second rib sufficiently to allow surgical accessthrough the intercostal incision via the inner opening of the surgicalretractor.
 2. The surgical retractor of claim 1, further comprising agroove within at least one of the first concave surface and the secondconcave surface sized and configured to avoid applying pressure to anintercostal nerve adjacent to the intercostal incision when theinflatable ring-shaped member is inflated.
 3. The surgical retractor ofclaim 1, wherein the first concave surface and the second concavesurface are part of a continuous concave outer surface encircling theinflatable ring-shaped member.
 4. The surgical retractor of claim 1,wherein the inflatable ring-shaped member further comprises a firstinflatable column member and a second inflatable column memberintervening between the portions of the inflatable ring-shaped memberadjacent to the first concave surface and the second concave surface,the first inflatable column member and the second inflatable columnmember, when inflated, having a greater cross sectional area than theportions of the inflatable ring-shaped member adjacent to the firstconcave surface and the second concave surface in order to providegreater force to separate the first rib and the second rib.
 5. Thesurgical retractor of claim 1, wherein the inflatable ring-shaped memberhas a diameter and a height, and wherein the diameter is greater thanthe height.
 6. The surgical retractor of claim 1, further comprising asubstantially rigid ring positioned within the inner opening of theinflatable ring-shaped member to support and rigidify the inflatablering-shaped member.
 7. The surgical retractor of claim 6, furthercomprising means for mounting a surgical device or instrument onto thesubstantially rigid ring.
 8. The surgical retractor of claim 1, furthercomprising a plurality of substantially rigid retractor bladespositioned within the inner opening of the inflatable ring-shaped memberto support the inflatable ring-shaped member.
 9. The surgical retractorof claim 8, wherein the plurality of substantially rigid retractorblades are mounted on a substantially rigid ring or rod.
 10. Thesurgical retractor of claim 8, wherein the substantially rigid ring orrod is releasably connected to the plurality of substantially rigidretractor blades.
 11. The surgical retractor of claim 8, furthercomprising means for mounting a surgical device or instrument onto oneof the plurality of substantially rigid retractor blades.
 12. A methodof surgical access comprising: making an intercostal incision in apatient's thorax; positioning a surgical retractor comprising aninflatable ring-shaped member in the intercostal incision; engaging afirst rib adjacent to the intercostal incision with a first concavesurface on an outer surface of the inflatable ring-shaped member;engaging a second adjoining rib adjacent to the intercostal incisionwith a second concave surface on the outer surface of the inflatablering-shaped member; inflating the inflatable ring-shaped member to openup an inner opening for surgical access through the surgical retractorand to separate the first rib and the second rib sufficiently to allowsurgical access through the intercostal incision via the inner openingof the surgical retractor.
 13. The method of claim 12, wherein theinflatable ring-shaped member comprises a groove within at least one ofthe first concave surface and the second concave surface, and whereinthe method further comprises positioning the groove so as to avoidapplying pressure to an intercostal nerve adjacent to the intercostalincision when the inflatable ring-shaped member is inflated.
 14. Themethod of claim 12, further comprising supporting the inflatablering-shaped member with a substantially rigid ring positioned within theinner opening of the inflatable ring-shaped member.
 15. The method ofclaim 12, further comprising supporting the inflatable ring-shapedmember with a plurality of substantially rigid retractor bladespositioned within the inner opening of the inflatable ring-shapedmember.
 16. The method of claim 15, further comprising mounting theplurality of substantially rigid retractor on a substantially rigid ringor rod.
 17. The method of claim 16, further comprising removing thesubstantially rigid ring or rod after positioning the plurality ofsubstantially rigid retractor blades.
 18. A surgical retractorcomprising: a first retractor blade made of a substantially rigidmaterial and having a first surface sized and configured to engage afirst rib of a patient adjacent to an intercostal incision; a firstinflatable member sized and configured to conform to the first surfaceof the first retractor blade and configured, when inflated, to provide acushioned surface between the first retractor blade and the first riband surrounding tissue; a second retractor blade made of a substantiallyrigid material and having a second surface sized and configured toengage a second adjoining rib adjacent to the intercostal incision; asecond inflatable member sized and configured to conform to the secondsurface of the second retractor blade and configured, when inflated, toprovide a cushioned surface between the second retractor blade and thesecond rib and surrounding tissue; and a mechanism configured toforcibly separate the first retractor blade and the second retractorblade to create a space for surgical access through the intercostalincision.
 19. The surgical retractor of claim 18, wherein the firstinflatable member, when inflated, is configured to have a first concavesurface sized and configured to atraumatically engage the first rib ofthe patient, and the second inflatable member, when inflated, isconfigured to have a second concave surface sized and configured toatraumatically engage the second rib of the patient.
 20. The surgicalretractor of claim 18, further comprising a groove formed in at leastone of the first inflatable member and the second inflatable membersized and configured to avoid applying pressure to an intercostal nerveadjacent to the intercostal incision.
 21. The surgical retractor ofclaim 18, further comprising means for mounting a surgical device orinstrument onto the surgical retractor.
 22. A method of surgical accesscomprising: making an intercostal incision in a patient's thorax;positioning a surgical retractor in the intercostal incision, thesurgical retractor comprising a first retractor blade made of asubstantially rigid material and having a first surface sized andconfigured to engage a first rib of a patient adjacent to an intercostalincision, a first inflatable member sized and configured to conform tothe first surface of the first retractor blade, a second retractor blademade of a substantially rigid material and having a second surface sizedand configured to engage a second adjoining rib adjacent to theintercostal incision, and a second inflatable member sized andconfigured to conform to the second surface of the second retractorblade; engaging a first rib adjacent to the intercostal incision withthe first retractor blade; engaging a second adjoining rib adjacent tothe intercostal incision with the second retractor blade; inflating thefirst inflatable member to provide a cushioned surface between the firstretractor blade and the first rib and surrounding tissue; inflating thesecond inflatable member to provide a cushioned surface between thesecond retractor blade and the second rib and surrounding tissue; andforcibly separating the first retractor blade and the second retractorblade to create a space for surgical access through the intercostalincision.
 23. The method of claim 22, wherein the surgical retractorfurther comprises a groove formed in at least one of the firstinflatable member and the second inflatable member, and wherein themethod further comprises positioning the groove so as to avoid applyingpressure to an intercostal nerve adjacent to the intercostal incision.24. The method of claim 22, further comprising mounting a surgicaldevice or instrument onto the surgical retractor.
 25. The method ofclaim 22, further comprising stabilizing an area of tissue on thepatient's beating heart with a tissue stabilizer mounted onto thesurgical retractor.